JUROCLAV 50 BROAD SPECTRUM ANTIBIOTIC TABLETS

Kraj: Australia

Język: angielski

Źródło: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Kup teraz

Ulotka dla pacjenta (PIL)

20-06-2017

Charakterystyka produktu (SPC)

20-06-2017

Arkusz danych dotyczących bezpieczeństwa (SDS)

10-07-2008

Składnik aktywny:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM CLAVULANATE

Dostępny od:

ZOETIS AUSTRALIA PTY LTD

INN (International Nazwa):

clavulanic acid as K salt(10mg/Tb)+amoxycillin as trihydrate(40mg/Tb)

Forma farmaceutyczna:

ORAL TABLET

Skład:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 40.0 mg/Tb; CLAVULANIC ACID AS POTASSIUM CLAVULANATE ANTIBIOTIC Active 10.0 mg/Tb

Sztuk w opakowaniu:

100 Tablets

Klasa:

VM - Veterinary Medicine

Grupa terapeutyczna:

Dziedzina terapeutyczna:

ANTIBIOTIC & RELATED

Wskazania:

Podsumowanie produktu:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION]; For the treatment of bacterial infections sensitive to clavulanic acid and amoxicillin in dogs and cats.Do not administer to small herbivores (e.g. guinea pigs) or animals with a history of allergic reactions to penicillins.

Status autoryzacji:

Registered

Data autoryzacji:

2023-07-01

Ulotka dla pacjenta

READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
DO NOT ADMINISTER TO SMALL HERBIVORES (E.G. GUINEA PIGS) OR ANIMALS
WITH A
HISTORY OF ALLERGIC REACTIONS TO PENICILLINS.
FOR ORAL ADMINISTRATION ONLY. JUROCLAV 50 Broad Spectrum Antibiotic
Tablet may
be accepted from the hand or alternatively, the tablets may be crushed
and added
to a little food.
DOSE: The standard dose rate is 12.5 mg / kg bodyweight (1 tablet per
4 kg) twice
daily. The following table is intended as a guide to dispensing
Juroclav 50 Broad
Spectrum Antibiotic Tablets.
100 TABLETS
Store below 25°C (Air conditioning) in a dry place.
1-2
3.5
6-9
10-13
14-18
1½
1
2
3
4
Dispose of empty container by wrapping with
paper and placing in garbage.
APVMA Approval No. 61669/100 Tab /0408
FIRST AID: If poisoning occurs contact a doctor or Poisons Information
Centre. Phone Australia 13 11 26.
100 TABLETS
128 mm
FILE NAME : 61669_41359_100TAB_IMMEDIATE_MPL_V01
DIMENSIONS: IMMEDIATE PACK = 128 MM X 40MM X 50MM
SCALE : 70% ON A3
DATE : 3 JULY 2008
ACTIVE CONSTITUENTS:
_10 MG _CLAVULANIC ACID as clavulanate potassium
_40 MG _ AMOXICILLIN as amoxicillin trihydrate
For the treatment of bacterial infections sensitive to clavulanic acid
and amoxicillin in dogs and cats.
EACH TABLET CONTAINS
Code No. :
B. No.:
Exp.
xxxxx
Item Code : 409810
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
DO NOT ADMINISTER TO SMALL HERBIVORES (E.G. GUINEA PIGS) OR ANIMALS
WITH A
HISTORY OF ALLERGIC REACTIONS TO PENICILLINS.
FOR ORAL ADMINISTRATION ONLY. JUROCLAV 50 Broad Spectrum Antibiotic
Tablet may
be accepted from the hand or alternatively, the tablets may be crushed
and added
to a little food.
DOSE: The standard dose rate is 12.5 mg / kg bodyweight (1 tablet per
20 kg) twice
daily. The following table is intended as a guide to dispensing
Juroclav 50 Broad
Spectrum Antibiotic Tablets.
100 TABLETS
Store below 25°C (Air conditioing) in a dry place.
1-2
3.5
6-9
10-13
14-18
1½
1
2
3
4
Dispose of empty container by wrapping with
paper and placing i

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Charakterystyka produktu

JUROCLAV TABLETS
Page 1 of 6
continued
ISSUED:
19 NOVEMBER 2012
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
JUROCLAV BROAD SPECTRUM ANTIBIOTIC TABLETS
PRODUCT CODE:
503585 (50 mg x 100’s); 503590 (250 mg x 250’s); 503595 (500 mg x
100’s)
RECOMMENDED USE:
For the treatment of bacterial infections sensitive to clavulanic acid
and
amoxicillin in dogs, cats and calves.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
131126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9a.m. – 5p.m.)
SECTION 2: HAZARDS IDENTIFICATION
GHS HAZARD CLASSIFICATIONS:
EYE IRRITATION CATEGORY 2A
RESPIRATORY SENSITIZER CATEGORY 1
SKIN CORROSION/IRRITATION CATEGORY 2
SKIN SENSITISER CATEGORY 1
STOT-SE CATEGORY 3
GHS PICTOGRAMS*:
EXCLAMATION MARK
HEALTH HAZARD
SIGNAL WORD*:
DANGER
HAZARD STATEMENTS*:
Causes skin irritation.
Many cause an allergic skin reaction.
Causes serious eye irritation.
May cause allergy or asthma symptoms or breathing difficulties if
inhaled.
May cause respiratory irritation.
PRECAUTIONARY STATEMENTS*:
PREVENTION
Avoid breathing dust.
Wash hands thoroughly after handling.
Use only outdoors or in a well-ventilated area.
Contaminated work clothing should not be allowed out of the workplace.
Wear protective gloves.
Use personal protective equipment as required.
In case of inadequate ventilation wear respiratory protection.
RESPONSE
IF ON SKIN: Wash with plenty of soap and water.
IF INHALED: Remove victim to fresh air and keep at rest in a position
comfortable for
breathing.
IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTRE or doctor if you feel unwell.
If skin irritation or rash occurs: Get medical advice.
If eye irritation persists: Get medical advice.
JUROCLAV TABLETS
Page 2 of 6
continued
If experiencing respiratory symptoms: Call a POISON CE

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WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Each tablet of Juroclav 50, Juroclav 250 or Juroclav 500 contains both
clavulanic acid (as clavulanate potassium) 10 mg, 50 mg or
100 mg; and amoxicillin (as amoxicillin trihydrate) 40 mg, 200 mg or
400 mg.
ACTIONS
Resistance to many antibiotics is caused by β-lactamase enzymes which
destroy the antibiotic before it can act on the bacteria. The
clavulanate in Juroclav counteracts this defence mechanism by
inactivating the β-lactamases, thus rendering the organisms sensitive
to amoxicillin’s rapid bactericidal effect at concentrations readily
attainable in the body.
MICROBIOLOGY
In vitro, Juroclav is active against a wide range of clinically
important bacteria, including:-
•
GRAM-POSITIVE BACTERIA: _Staphylococcus _spp. (including β-lactamase
producing strains), _Corynebacterium_ spp. and _Streptococcus_ spp.;
•
GRAM-NEGATIVE BACTERIA: _Escherichia coli _(including β-lactamase
producing strains), _Salmonella_ spp. (including β-lactamase
producing
strains), _Bordetella bronchiseptica_, _Pasteurella _spp_., Proteus
mirabilis_ and other sensitive strains and _Klebsiella _spp.
Juroclav is not indicated for cases involving _Pseudomonas_ spp.
INDICATIONS
JUROCLAV 50 AND 250 TABLETS: Clinically, Juroclav has been shown to be
effective in treating a wide range of diseases of cats and
dogs, including skin disease (deep and superficial pyodermas), urinary
tract infection, respiratory disease (involving upper and lower
respiratory tract) and enteritis. They have a notably broad spectrum
of bactericidal activity against bacteria commonly found in cats
and dogs, and are indicated for the oral treatment of bacterial
infections caused by susceptible organisms.
JUROCLAV 500 TABLETS: Have a notably broad spectrum of bactericidal
activity against bacteria commonly found in calves and dogs
and are indicated for the oral treatment of bacterial infections
caused by susceptible organisms. These incl

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